Agno Pharma provides comprehensive ICH-compliant stability programs that are integral to successful drug development plans. With a strong emphasis on quality, we offer extensive stability testing services complementing our development and manufacturing capabilities. Our facility boasts ample storage capacity, equipped with state-of-the-art technology and software fully compliant with regulatory standards, ensuring a seamless experience for all stability testing needs.

We specialize in custom ICH programs tailored to meet specific client requirements, addressing crucial factors such as time, temperature, and the nature of both APIs and finished dosage forms. These programs are designed to provide stability data essential for every stage of regulatory submission, from Phase I trials through to marketing authorization filings. Our facility accommodates storage for both semi-permeable and impermeable containers under controlled conditions.

Conditions include:

• Impermeable containers for API and DP
  • -80 °C
  • -20 °C
  • 5 °C
  • 25 °C/60% RH
  • 30 °C/65% RH
  • 40 °C/75% RH

• Semi-permeable containers for DP
  • 25 °C/40% RH
  • 40 °C/NMT 25% RH

• Chambers that can be qualified at the appropriate temperature/humidity for various ICH climatic zones

At Agno Pharma, we conduct thorough photostability studies in full compliance with the ICH Q1B guidance document. Our systematic approach starts with evaluating the impact of specific light intensities and wavelengths on API.  We then extend this analysis to the drug product itself and, if necessary, to both immediate and clinical/marketing packaging.

This comprehensive evaluation helps us identify the handling precautions and processing protections required during formulation and manufacturing to prevent degradation. Additionally, our findings guide the selection of optimal immediate and final packaging solutions, ensuring the product’s stability throughout its shelf life.

At Agno Pharma, we believe in accelerating the drug development cycle and minimizing risks by offering a comprehensive suite of services, including stability testing, under one roof. We have invested in advanced electronic lab management systems for efficient stability program management and data collection, ensuring robust reporting for our clients.